MODIFICATION OF SURGICAL EYESHIELD MASK
Device Facts
| Record ID | K934085 |
|---|---|
| Device Name | MODIFICATION OF SURGICAL EYESHIELD MASK |
| Applicant | American Threshold Industries, Inc. |
| Product Code | HOY · Ophthalmic |
| Decision Date | Nov 12, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4750 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.
